Sutab Tablet
NDC Package 52268-201-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is sUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. This formulation utilizes a tablet delivery system. Marketed by Braintree Laboratories, Inc., this product is identified by NDC 52268-201 and is authorized under FDA application NDA213135.

Identification & Billing

NDC Package Code
52268-201-01
Package Description
2 BOTTLE, PLASTIC in 1 KIT / 12 TABLET in 1 BOTTLE, PLASTIC
Product Code
52268-201
11-Digit Billing Format
52268020101

Clinical Specifications

Proprietary Name
Sutab
Non-Proprietary Name
Sodium Sulfate, Magnesium Sulfate, And Potassium Chloride
Substance Name
Magnesium Sulfate Anhydrous; Potassium Chloride; Sodium Sulfate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

Regulatory & Marketing

Labeler Name
Braintree Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213135
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-10-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52268-201-01 identifies a specific commercial package of 2 bottle, plastic in 1 kit / 12 tablet in 1 bottle, plastic of Sutab, a human prescription drug labeled by Braintree Laboratories, Inc.. This tablet is formulated for oral use and contains magnesium sulfate anhydrous; potassium chloride; sodium sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Braintree Laboratories, Inc. on November 10, 2020. The current certification is valid through December 31, 2026.

How is this Braintree Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52268020101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52268-201-01
11-Digit CMS (5-4-2)
52268-0201-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.